Annexon's Eye Disease Drug Reports Mixed Trial Results, Will Focus On Planned Late-Stage Study

  • Annexon Inc ANNX announced topline results from its ARCHER Phase 2 trial of ANX007 in patients with geographic atrophy (GA).
  • ANX007 was not statistically significant compared to pooled sham, the comparator, at 12 months in patients with geographic atrophy. 
  • In every-month dosing, the GA lesion area changed about 6.2% from baseline (p=0.526), 1.3% (p=0.896) in the every-other-month group, and a 3.7% reduction was observed in the pooled patient population (p-value=0.673).
  • Patients in the monthly treatment group showed a 72% reduction in the risk of 15-letter loss (p=0.006), and patients in the every-other-month treatment group showed a 48% reduction in the risk of 15-letter loss (p=0.064).
  • Patients in the pooled treatment group showed a 59% reduction in risk of >15-letter loss (p=0.008).
  • ANX007 was generally well tolerated as both a monthly and every-other-month treatment.
  • Annexon said ANX007 was “generally well-tolerated,” noting there were three cases of endophthalmitis or inflammation on the inner shield of the eye, but they were found to be administration-related, not treatment-related.
  • The six-month off-treatment follow-up period of the ARCHER Phase 2 trial is ongoing, and Annexon plans to report the final results following the study conclusion.
  • Price Action: ANNX shares are 23.60% lower at $3.95 during premarket trading on the last check Thursday.
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